BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 2921955 · Received January 18, 2013

    Report

    Report Number
    9612164-2013-00086
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSION: (ROOT CAUSE OF MARKER BAND DISTORTION IS MOST LIKELY PROCEDURAL RELATED). (DEVICE USED IN THE SFA/PROFUNDA BIFURCATE-COMPLETE SE IS INDICATED FOR USE IN THE ILIAC VESSELS). (IMAGES APPEAR TO CONFIRM THE MARKER BAND DISTORTION). (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN DEPLOYED A 6MM DIAMETER X 80MM LENGTH COMPLETE SE PERIPHERAL STENT SYSTEM IN THE SFA/ PROFUNDA BIFURCATION OF A PATIENT TO TREAT A 100% STENOSIS CTO LESION THAT WAS PRE-DILATED. IT WAS REPORTED THAT FOLLOWING STENT DEPLOYMENT, THE PROXIMAL PORTION OF THE STENT LOOKED LIKE TWO OF THE MARKERS FOLDED OVER ON ITS SELF. NO PATIENT INJURY AND NO CLINICAL SEQUELAE WERE REPORTED. IMAGE REVIEW: TWO STILL PROCEDURAL IMAGES OF THE DEPLOYED COMPLETE SE STENT WERE PROVIDED FOR REVIEW. THE STILL PROCEDURAL IMAGES APPEAR TO CONFIRM THE MARKER BAND DISTORTION. THE LESION WAS LOCATED IN THE SFA/PROFUNDA BIFURCATE AND WAS A 100% STENOSIS CTO. THE STILL IMAGES SHOW THE DEPLOYED STENT WITH A NON-CONCENTRIC PROFILE THAT TAPERS DOWN THE VESSEL MOST LIKELY DUE TO THE MORPHOLOGY OF THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27705 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0005903220

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR